All documents shown here are included in the seminar for instant download

Labcompliance On-line Audio Seminar

This seminar has been recorded and is
available on CD and for instant download. All reference material as
listed below and more is available on a special seminar website. The
website is regularly updated with most recent information. In case
there are questions related to the topic, they can be submitted
through a web form and will be answered by the speaker. For ordering
info
click here
To share this seminar info with your colleagues,
click here.

Testimonials

So far we have received very positive
feedback from attendees of Ludwig Huber's seminars on
Computer System Validation. To learn how the
seminar and the Labcompliance Computer System Validation package
helped to validate software and computer systems,
click here.

On-line Audio Seminar 284

Qualification of Virtual Networks and
Cloud Computing

With Strategies
and Tool Kit for Compliance and System Uptime

Recorded, available with all reference material
at any time

Virtual networks and cloud computing can significantly reduce investment and
operating costs for IT operations. However when used in FDA and other regulated
environments they need to be qualified to ensure consistent on-going performance
and security and integrity of stored and managed data. While there are
guidelines available on how to deal with standard networks this is not the case
for virtual networks and cloud computing

What is the difference between qualification of Virtual
Machines vs. Physical Servers?

What are the advantages and disadvantages of virtual
networks and cloud computing in FDA regulated environment?

Do the FDA and other agencies allow the use of virtual
networks and cloud computing?

What are the main compliance risks for cloud storage and
computing?

What exactly are the expectations of
inspectors for qualification?

How to apply risk management for VM and cloud computing?

Do we need to follow a lifecycle model for qualification?

How to implement GMP requirements to cloud computing?

Do the benefits of virtual networks and cloud computing
justify the additional effort to comply?

How to document the use virtual networks and cloud computing
for the FDA?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber
in a new interactive audio seminar. During the seminar, the speaker
will present strategies and an overview and give practical
recommendations. After the seminar, an extensive list of reference
material like SOPs, templates and examples will help immediate and
cost effective implementation.

During the interactive presentation you learn
about:

Benefits of virtual networks and cloud computing

Possible issues when used in FDA regulated environments

Recommendations from official task forces

Infrastructure qualification vs. system validation

How to deal with major issues: security, data availability
and data integrity

Going through a complete project for virtual network
qualification

Specific considerations for change control

Recommendations for different cloud versions:
internal/external private, public

Issues with different cloud services: platform,
infrastructure and software

Responsibilities: the importance of quality agreements with
service providers

Step-by-step recommendations for using 'clouds' from
planning to reporting

Putting everything together: documentation for the FDA and
every other agency

And for easy and instant implementation:
download 10+ documents from special seminar website

SOP: Risk Based Qualification of Network
Infrastructure

SOP: Qualification of Virtual
Networks

SOP: Using Cloud Computing in
Regulated Environments

SOP: Using the Internet in Regulated Environments

SOP: Validation of Web-Based Applications

SOP: Using the Internet in Regulated
Environments

SOP: Change Control for Networks and
Systems - Planned Changes

SOP: Change Control for Networks and
Systems - Unplanned Changes

SOP: Development and Maintenance of Test
Scripts for Equipment Hardware&Software

Please forward to your colleagues

About audio seminars

Online audio seminars are
presented over the phone. During the live presentation attendees
can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a
seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith,
FDA's national Part11 expert, at a panel discussion with
Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about
computer system validation and e-records.

Testimonials/References

The Feedbacks on the Ludwig
Huber's seminars and validation packages have
been received by e-mails. Labcompliance has permission to use
the testimonials as references. Original e-mails are stored in
the Labcompliance archive.

Audio Seminar:
IT Infrastructure and Network Qualification: Step-by-StepFeedback:
I'm new to the GxP IT world. The seminar was
useful. I quickly gained an overview of network qualification.
I would recommend the seminar to other IT professionals.Mr. Carmelo Rodriges, Amicus Therapeutics,
Director Information TechnologyDepartment, USA,
USA
(Ref T-1005).

Audio Seminar:
Infrastructure and Network Qualification: Step-by-StepFeedback:
The seminar did exceed my expectations. It was a
very good seminar and I learn more from it than from the published
guides on the topicMr. FrancoisNjieha,
, Kwelong, Inc., CSV Engineer,
USA(Ref T-1011)..

Audio Seminar:
IT Infrastructure and Network Qualification: Step-by-StepFeedback:
The seminar did exceed my expectations. All parts
of networks and infrastructure that I remember were clearly addressed.
Thank you and congratulations!Mr.
Paulo Marques, Bial,
IT/IS Quality Assurance, Portugal (T-1012).